BEUDAMED
    FDA Adverse Event Summary report: N

    DAILY ACTIVITY ASSIST DEVICES

    MDR report key: 3729458 · Received April 7, 2014

    Report

    Report Number
    1531186-2014-01180
    Date Received
    April 7, 2014
    Report Date
    March 6, 2014
    Manufacturer
    KENSTONE METAL
    Product Code
    IKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATES THAT HIS FRONT RIGGING ON THE LEFT SIDE THE WELD WHERE THE FOOTPLATE ATTATCHES IS COMING APART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206977 DAILY ACTIVITY ASSIST DEVICES 890.5050 IKX KENSTONE METAL 6895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other